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Multiple Courses of Antenatal Corticosteroids for Preterm Birth Study (MACS)

Primary Purpose

Pregnancies at Increased Risk of Preterm Birth

Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Multiple vs. single courses of antenatalcorticosteroids
Sponsored by
Sunnybrook Health Sciences Centre
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pregnancies at Increased Risk of Preterm Birth focused on measuring antenatal corticosteroids, preterm birth, multiple versus single doses, follow-up

Eligibility Criteria

14 Years - 45 Years (Child, Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Women who have previously received one completed course of ACS, at least 14 days ago and continue to be at increased risk of preterm birth Gestational age greater ≥ 26 weeks and gestational age < 31 weeks Exclusion Criteria: Women requiring chronic doses of corticosteroids secondary to medical conditions Women with a contraindication to corticosteroids Women with clinical evidence of chorioamnionitis (temperature ≥ 38°c) Known lethal congenital anomaly (e.g. anencephaly)

Sites / Locations

  • Data Coordinating Centre, CMICR 790 Bay Street, 7th Floor

Outcomes

Primary Outcome Measures

MACS: Perinatal or neonatal mortality or serious neonatal morbidity
MACS-5: Mortality or survival with severe neuro-morbidities at 5 years of age

Secondary Outcome Measures

MACS: Death or neurologic impairment at 2 years of age
MACS-5: Measures of growth and blood pressure assessed by clinical exam
MACS-5: At Canadian sites, abnormalities in intelligence and specific cognitive skills (WPPSI-III, Beery: VMI and PPVT-III)

Full Information

First Posted
September 13, 2005
Last Updated
June 14, 2010
Sponsor
Sunnybrook Health Sciences Centre
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1. Study Identification

Unique Protocol Identification Number
NCT00187382
Brief Title
Multiple Courses of Antenatal Corticosteroids for Preterm Birth Study (MACS)
Official Title
Multiple Courses of Antenatal Corticosteroids for Preterm Birth Study (MACS)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
April 2001 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
December 2011 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Sunnybrook Health Sciences Centre

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
In women at 26 to 30 weeks gestation and who are risk for threatened early birth, who have not had their baby by 14 or more days after being given a single course of antenatal corticosteroids (ACS), do repeated courses of ACS every 14 days until 33 weeks' gestational age lower the risk of illness or death in babies compared to repeated courses of placebo. Children are assessed at 2 years and 5 years for neurodevelopmental impairment.
Detailed Description
In women at 26 to 30 weeks gestation, who are at increased risk for preterm birth and remain undelivered 14 or more days following a single course of antenatal corticosteroids (ACS), are multiple course of ACS every 14 days until 33 weeks effective in reducing the risk of perinatal or neonatal mortality or significant neonatal morbidity, compared to placebo. 18-24 Month Follow-up: Children (18-24 months corrected gestational age) are assessed with the Bayley Scales of Infant Development (Second Edition) to determine neurodevelopmental impairment. 5 Year Follow-up (MACS-5): Children are assessed using the Child Behaviour Checklist (1 1/2 - 5) and the Behaviour Rating Inventory of Executive Function (Preschool version) to determine neurocognitive function.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancies at Increased Risk of Preterm Birth
Keywords
antenatal corticosteroids, preterm birth, multiple versus single doses, follow-up

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1858 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Multiple vs. single courses of antenatalcorticosteroids
Primary Outcome Measure Information:
Title
MACS: Perinatal or neonatal mortality or serious neonatal morbidity
Title
MACS-5: Mortality or survival with severe neuro-morbidities at 5 years of age
Secondary Outcome Measure Information:
Title
MACS: Death or neurologic impairment at 2 years of age
Title
MACS-5: Measures of growth and blood pressure assessed by clinical exam
Title
MACS-5: At Canadian sites, abnormalities in intelligence and specific cognitive skills (WPPSI-III, Beery: VMI and PPVT-III)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women who have previously received one completed course of ACS, at least 14 days ago and continue to be at increased risk of preterm birth Gestational age greater ≥ 26 weeks and gestational age < 31 weeks Exclusion Criteria: Women requiring chronic doses of corticosteroids secondary to medical conditions Women with a contraindication to corticosteroids Women with clinical evidence of chorioamnionitis (temperature ≥ 38°c) Known lethal congenital anomaly (e.g. anencephaly)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kellie Murphy, M.D.
Organizational Affiliation
MOUNT SINAI HOSPITAL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Data Coordinating Centre, CMICR 790 Bay Street, 7th Floor
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1N8
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
25123162
Citation
Asztalos E, Willan A, Murphy K, Matthews S, Ohlsson A, Saigal S, Armson A, Kelly E, Delisle MF, Gafni A, Lee S, Sananes R, Rovet J, Guselle P, Amankwah K; MACS-5 Collaborative Group. Association between gestational age at birth, antenatal corticosteroids, and outcomes at 5 years: multiple courses of antenatal corticosteroids for preterm birth study at 5 years of age (MACS-5). BMC Pregnancy Childbirth. 2014 Aug 13;14:272. doi: 10.1186/1471-2393-14-272.
Results Reference
derived
PubMed Identifier
24126948
Citation
Asztalos EV, Murphy KE, Willan AR, Matthews SG, Ohlsson A, Saigal S, Armson BA, Kelly EN, Delisle MF, Gafni A, Lee SK, Sananes R, Rovet J, Guselle P, Amankwah K, Saleem M, Sanchez J; MACS-5 Collaborative Group. Multiple courses of antenatal corticosteroids for preterm birth study: outcomes in children at 5 years of age (MACS-5). JAMA Pediatr. 2013 Dec;167(12):1102-10. doi: 10.1001/jamapediatrics.2013.2764.
Results Reference
derived
PubMed Identifier
22525902
Citation
Murphy KE, Willan AR, Hannah ME, Ohlsson A, Kelly EN, Matthews SG, Saigal S, Asztalos E, Ross S, Delisle MF, Amankwah K, Guselle P, Gafni A, Lee SK, Armson BA; Multiple Courses of Antenatal Corticosteroids for Preterm Birth Study Collaborative Group. Effect of antenatal corticosteroids on fetal growth and gestational age at birth. Obstet Gynecol. 2012 May;119(5):917-23. doi: 10.1097/AOG.0b013e31825189dc.
Results Reference
derived
PubMed Identifier
20956409
Citation
Asztalos EV, Murphy KE, Hannah ME, Willan AR, Matthews SG, Ohlsson A, Kelly EN, Saigal S, Ross S, Delisle MF, Amankwah K, Guselle P, Gafni A, Lee SK, Armson BA, Sananes R, Tomat L; Multiple Courses of Antenatal Corticosteroids for Preterm Birth Study Collaborative Group. Multiple courses of antenatal corticosteroids for preterm birth study: 2-year outcomes. Pediatrics. 2010 Nov;126(5):e1045-55. doi: 10.1542/peds.2010-0857. Epub 2010 Oct 18.
Results Reference
derived

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Multiple Courses of Antenatal Corticosteroids for Preterm Birth Study (MACS)

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